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United States · US · US:0074-0561_5d893369-497c-46ee-9b64-ee737fab4225

Venclexta

Orange BookUNIISPLATC L01XX52

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAbbVie Inc.
CountryUS (United States)
ATC codeL01XX52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0074056111
    1 BLISTER PACK in 1 CARTON (0074-0561-11) / 2 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    0074056114
    1 BLISTER PACK in 1 CARTON (0074-0561-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
N54AIC43PW
VENETOCLAX
RxCUI 1747556
Orange Book
N208573
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "N54AIC43PW",
    "rxcui": "1747556",
    "inchikey": "LQBVNQSMGBZMKD-UHFFFAOYSA-N",
    "display_name": "VENETOCLAX",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b118a40d-6b56-cee3-10f6-ded821a97018": {
      "match": "brand_token",
      "title": "VENCLEXTA (VENETOCLAX) KIT VENCLEXTA (VENETOCLAX) TABLET, FILM COATED [ABBVIE INC.]",
      "spl_version": "282",
      "published_date": "2026-03-02"
    }
  },
  "productid": "0074-0561_5d893369-497c-46ee-9b64-ee737fab4225",
  "productndc": "0074-0561",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208573",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Apr 11, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Apr 11, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Apr 11, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VENETOCLAX",
  "proprietary_name": "Venclexta",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208573",
  "marketing_category": "NDA",
  "nonproprietary_name": "Venetoclax",
  "start_marketing_date": "20160411",
  "active_numerator_strength": "10"
}

Related drugs

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